Recent FDA Approvals (through January 2011) related to Fortesta, Natroba, Abstral, Acetadote, Viibryd, Intelence
Testosterone Gel (Fortesta, Endo Pharmaceuticals) for topical use was approved as replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism or hypogonadotrophic hypogonadism.
Spinosad (Natroba, ParaPRO LLC) Topical Suspension 0.9% was approved for the treatment of head lice infestation in patients aged 4 years and older.
Fentanyl (Abstral, ProStrakan) transmucosal tablets were approved to manage breakthrough pain for adults aged ≥18 years with cancer, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medication.
Vilazodone HCl tablets (Viibryd, Clinical Data) was approved for the treatment of major depressive disorder in adults.
A label update for etravirine (Intelence, Tibotec), a non-nucleoside reverse transcriptase inhibitor (NNRTI), was approved to include a 200-mg formulation. Intelence is indicated for the treatment of HIV in treatment-experienced adults with resistance to an NNRTI and other antiretroviral agents. The recommended oral dose of Intelence is 200 mg (one 200-mg tablet or two 100-mg tablets) taken twice daily following a meal. The new dosage strength will reduce the number of pills that some patients with HIV need to take daily. The 100-mg tablet will remain available.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
November 1st 2024Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.
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ICER Gives Cell Therapy for Post-Transplant Complications High Rating
Published: October 31st 2024 | Updated: October 31st 2024ICER has given tabelecleucel a rating of A, indicating the T cell therapy for Epstein-Barr virus related post-transplant lymphoproliferative disease has a high certainty of substantial net health benefit and would be cost-effective if priced between $143,900 and $273,700.
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